Abstract
Achieving high protocol adherence is essential for ensuring the overall success and scientific merit of clinical trials. Strategies for maximizing recruitment and treatment adherence have been previously explored in the literature. There has been less focus, however, on effective methods for maintaining participants in research follow-up. This article examines factors associated with poor follow-up rates as well as strategies for facilitating research commitment and addressing sources of nonadherence. Special attention is devoted to alcohol- and substance-dependent populations, groups known to have poor adherence rates. Examples are drawn from the COMBINE Study, an NIAAA-funded, nationwide, multisite, combined behavioral and pharmacotherapy trial for alcohol problems that achieved high one-year follow-up rates. The important role of coordinating centers in facilitating research retention is also discussed.
Similar content being viewed by others
References
Sibbald B, Roland M. Understanding controlled trials: why are randomised controlled trials important? Br Med J. 1998;316(7126):201.
Cramer J, Spilker B. Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press; 1991.
Friedman L, Furburg C, DeMets D. Fundamentals of Clinical Trials. New York: Springer-Verlag; 1998.
Spilker B, Cramer J. Patient Recruitment in Clinical Trials. New York: Raven Press; 1992.
Moyer A, Finney J, Swearingen C. Methodological characteristics and quality of alcohol treatment outcome studies, 1970–1998: an expanded evaluation. Addiction. 2002;97(3):253–263.
Pich J, Carne X, Arnaiz J, Gomez B, Trilla A, Rodes J. Role of a research ethics committee in followup and publication of results. Lancet. 2003;361:1015–1016.
Wittes R, Friedman M. Accrual to clinical trials. J Natl Cancer Inst. 1988;80(12):884–885.
Easterbrook P, Matthews D. Fate of research studies. J R Soc Med. 1992;85(2):71–76.
Edwards A, Rollnick S. Outcome studies of brief alcohol intervention in general practice: the problem of lost subjects. Addiction. 1997;12:1699–1704.
Howard K, Cox W, Saunders S. Attrition in substance abuse comparative research: the illusion of randomization. NIDA Research Monograph. 1990;104:68–79.
Mattson M, DelBoca F, Carroll K, et al. Compliance with treatment and follow-up protocols Project MATCH: predictors and relationship to outcome. Alcohol: Clin Exp Res. 1998;22(6):1328–1339.
Thomson C, Morley K, Teesson M, Sannibale C, Haber P. Issues with recruitment to randomised controlled trials in the drug and alcohol field: a literature review and Australian case study. Drug Alcohol Rev. 2008;27(2):115–122.
Carroll K, ed. Enhancing Retention in Clinical Trials of Psychosocial Treatments: Practical Strategics. Washington, DC: Government Printing Office; 1997.
Onken L, Blaine J, Boren J, eds. Beyond the Therapeutic Alliance: Keeping the Drug-Dependent Individual in Treatment. NIDA Research Monograph No. 165. DHHS Publication No. (ADM) 97–4142; No. 165.
Group PMR. Project MATCH: rationale and methods for a multisite clinical trial matching alcoholism patients to treatment. Alcohol Clin Exp Res. 1993;17(6):1130–1145.
Zweben A, Barrett D, Berger L, Murray K. Recruiting and retaining participants in a combined behavioral and pharmacological clinical trial. J Stud Alcohol. 2005;66(Suppl. 15):72–81.
Flick S. Managing attrition in clinical research. Clin Psychol Rev. 1988;8:499–515.
Atwood J, Haase J, Rees-McGee S, et al. Reasons related to adherence in community-based field studies. Patient Educ Counsel. 1992;19(3):251–259.
Bender B, Ellison M, Gleason M, Murphy J, Sundstrom D, Szefler S. Minimizing attrition in a longterm clinical trial of pediatric asthma. Ann Allergy Asthma Immunol. 2003;91:168–176.
Cassidy E, Baird E, Sheikh J. Recruitment and retention of elderly patients in clinical trials. Am J Ger Psychiatry. 2001;9:136–140.
Moser D, Dracup K, Doering L. Factors differentiating dropouts from completers in a longitudinal, multicenter clinical trial. Nurs Res. 2000;49(2):109–116.
May D, Kratochvil C, Puumala S, Silva S, Rezac A, Hallin M. A manual based intervention to address clinical crises and retain patients in the treatment of adolescents with depression study (TADS). J Am Acad Child Adolesc Psychiatry. 2006;46(5):573–581.
Cottler L, Compton W, Ben-Abdallah A, Horne M, Claverie D. Achieving a 96.6 percent follow-up rate in a longitudinal study of drug abusers. Drug Alcohol Depend. 1996;41:209–217.
Scott C. A replicable model for achieving over 90% follow-up rates in longitudinal studies of substance abusers. Drug Alcohol Depend. 2004;74:21–36.
Callaghan R, Hathaway A, Cunningham J, Vettese L, Wyatt S, Taylor L. Does stage-of-change predict dropout in a culturally diverse sample of adolescents admitted to inpatient substance abuse treatment? A test of the transtheoretical model. Addict Behav. 2005;30:1834–1847.
DiClemente C, Schlundt D, Gemmell L. Readiness and stages of change in addiction treatment. Am J Addict. 2004;13(2):103–119.
Dickert N, Grady C. What’s the price of a research subject? Approaches to payment for research participation. N Engl J Med. 1999;341(3):198–203.
Fry C, Dwyer R. For love or money? An exploratory study of why injecting drug users participate in research. Addiction. 2001;96:1319–1325.
Koocher G. Questionable methods in alcoholism research. J Consult Clin Psychol. 1991;59(2):246–248.
McGee G. A piece of my mind. Subject to payment? JAMA. 1997;278(3):199–200.
McKeganey N. To pay or not to pay: respondents’ motivation for participating in research. Addiction. 2001;96:1237–1238.
Shaner A, Eckman T, Robert L, et al. Disability income, cocaine use, and repeated hospitalization among schizophrenic cocaine abusers—a government sponsored revolving door? N Engl J Med. 1995;333:777–783.
Cunningham J, Sobell L, Chow V. What’s in a label? The effects of substance types and labels on treatment considerations and stigma. J Stud Alcohol. 1993;54(6):693–699.
Mark T, Kranzler H, Poole V, Hagen C, McLeod C, Crosse S. Barriers to the use of medications to treat alcoholism. Am J Addict. 2003;12(4):281–294.
Anton R, O’Malley S, Ciraulo D, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence. The COMBINE Study: a randomized controlled trial. JAMA. 2006;295:2003–2017.
Desmond D, Maddux J, Johnson T, Confer B. Obtaining follow-up interviews for treatment evaluation. J Subst Abuse Treat. 1995;12(2):95–102.
McCrady B, Bux D. Ethical issues in informed consent with substance abusers. J Clin Invest. 1999;67:186–193.
Grady C. Payment of clinical research subjects. J Clin Invest. 2005;115:1681–1687.
Amass L, Bickel W, Crean J, Higgins S, Badger G. Preferences for clinic privileges, retail items and social activities in an outpatient treatment program. J Subst Abuse Treat. 1996;13(1):43–49.
Kurlander J, Simon-Dack S, Gorelick D. Spending of remuneration by subjects in non-treatment drug abuse research studies. Am J Drug Alcohol Abuse. 2006;32:527–540.
Festinger D, Marlowe D, Croft J, et al. Do research payments precipitate drug use or coerce participation? J Drug Alcohol Depend. 2005;78:275–281.
Miller W. Form 90: A Structured Assessment Interview for Drinking and Related Behaviors Test Manual. NIAAA Project MATCH Monograph Series. NIH Publication No. 96-4944. Vol 5. Bethesda, MD: Department of Health and Human Services; 1996.
Barrett D, Morse P, eds. Handling Noncompliance. Bethesda, MD: Department of Health and Human Services; 1998.
Zweben A, Barrett D, Carty K, McRee B, Morse P, Rice C, eds. Strategies for Facilitating Protocol Compliance in Alcoholism Treatment Research. NIAAA Project MATCH Monograph Series. NIH Publication No. 98-4144. Bethesda, MD: Department of Health and Human Services; 1998; No. 7.
McRee B, ed. Project MATCH: A Case Study. Bethesda, MD: Department of Health and Human Services; 1998.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Zweben, A., Fucito, L.M. & O’Malley, S.S. Effective Strategies for Maintaining Research Participation in Clinical Trials. Ther Innov Regul Sci 43, 459–467 (2009). https://doi.org/10.1177/009286150904300411
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286150904300411